BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures

SAN DIEGO, Jan. 2 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) , announced today that it received clearance from the U.S. Food and Drug Administration (FDA) for the BD GeneOhm(TM) StaphSR assay. This new assay is the first test available to rapidly and simultaneously identify two deadly healthcare-associated infections (HAIs) -- Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) -- from patients with positive blood cultures. It will help enable physicians to implement the right treatment at the right time for patients with bloodstream infections, thereby transforming patient care and significantly reducing healthcare costs.

"The BD GeneOhm StaphSR assay provides a rapid, definitive identification of SA and MRSA from blood cultures. This allows for more appropriate isolation procedures and agent-specific antimicrobial therapy, resulting in reduced patient morbidity and mortality as well as an overall reduction in healthcare costs," said Thomas Davis, M.D., Ph.D., Director of Clinical Microbiology, Wishard Memorial Hospital, Indianapolis, Indiana.

"The launch of the BD GeneOhm StaphSR assay in the United States further demonstrates BD's commitment to helping healthcare providers rapidly identify, prevent and control HAIs," said Vince Forlenza, Executive Vice President, BD. "It also illustrates our desire to provide customers with a complete menu of assays and tools to combat these potentially deadly infections."

The BD GeneOhm StaphSR assay provides results within two hours, directly from positive blood cultures. It is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results. Studies have shown that providing physicians with critical microbiology information earlier will result in decreased mortality, length of stay and variable costs.

Currently, the BD GeneOhm(TM) MRSA assay rapidly identifies patients who are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission. BD has recently submitted subsequent applications to the FDA for the BD GeneOhm StaphSR assay to add nasal swab and wound claims. BD is also developing rapid tests for the detection of two other organisms that cause severe HAIs. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile. These rapid assays will further complement the Company's portfolio of HAI-related products.

About BD

BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. For more information, please visit http://www.bd.com/.

This press release contains certain estimates and other forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future performance, products or other events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: competitive factors; pricing and market share pressures; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs and their effect on, among other things, the cost of producing BD's products; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; changes in healthcare or other governmental regulation; as well as other factors discussed in this press release and in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.